Topical peripheral neuro-affective (tpna) therapy for neuropathic conditions

Abstract

Formulations and methods of treating peripheral neuropathic conditions in humans is disclosed.

1 . A method of treating a peripheral neuropathic condition in humans, comprising topically administering a therapeutically effective amount of a drug selected from the group consisting of a dopamine agonist, a drug which enhances conduction of damaged demyelinated nerves, and a combination thereof at the site of the injury. 
     
     
         2 . The method of  claim 1 , wherein the dopamine agonist is selected from the group consisting of apomorphine, pramipexole, ropinirole, bromocriptine, cabergoline, pergolide, rotigotine, entacapone, tocapone, seligiline, and mixtures of any of the foregoing. 
     
     
         3 . The method of  claim 1 , wherein the drug which enhances conduction of damaged demyelinated nerves (e.g., a drug which blocks leaking potassium channels in damaged demyelinated nerves to improve conduction). 
     
     
         4 . The method of  claim 3 , wherein the drug is 4-aminopyridine, 3,4 diaminopyridine, tetraethylammonium (TEA), or combinations of any of the foregoing. 
     
     
         5 . The method of  claim 3 , wherein the drug which enhances conduction of damaged demyelinated nerves is 4-aminopyridine. 
     
     
         6 . The method of  claim 1 , further comprising topically administering an additional drug(s) to the site of the injury, the additional drug selected from the group consisting of gabapentin, pregabalin, duloxetine, and combinations of any of the foregoing. 
     
     
         7 . The method of  claim 1 , further comprising an additional agent(s) selected from the group consisting of L-methyl folate, methyl cobalamin, 5-pyridoxal phosphate, B1 benfotiamine, stabilized R-Alpha Lipoic Acid (R-ALA), gabapentin, pregabalin, pyridoxal 5′-phosphate, an opioid analgesic, a non-steroidal anti-inflammatory agent (NSAID), a local anesthetic, and mixtures of any of the foregoing. 
     
     
         8 . The method of  claim 1 , wherein the drug is apomorphine. 
     
     
         9 . The method of  claim 1 , further comprising an opioid agonist selected from the group consisting of alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, desomorphine, dextromoramide, dezocine, diampromide, diamorphone, dihydrocodeine, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, fentanyl, heroin, hydrocodone, hydromorphone, hydroxypethidine, isomethadone, ketobemidone, levorphanol, levophenacylmorphan, lofentanil, meperidine, meptazinol, metazocine, methadone, metopon, morphine, myrophine, narceine, nicomorphine, norlevorphanol, normethadone, nalorphine, nalbuphene, normorphine, norpipanone, opium, oxycodone, oxymorphone, papaveretum, pentazocine, phenadoxone, phenomorphan, phenazocine, phenoperidine, piminodine, piritramide, propheptazine, promedol, properidine, propoxyphene, sufentanil, tilidine, tramadol, salts of any of the foregoing, and mixtures of any of the foregoing. 
     
     
         10 . The method of  claim 8 , wherein the opioid agonist is tramadol in an amount from about 20 mg to about 40 mg. 
     
     
         11 . The method of  claim 8 , wherein the opioid agonist is morphine sulfate in an amount from about 2.5 to about 5 mg. 
     
     
         12 . The method of  claim 1 , wherein the drug is formulated in a pharmaceutically acceptable immediate release topical carrier. 
     
     
         13 . The method of  claim 11 , wherein the carrier is aqueous-based. 
     
     
         14 . The method of  claim 1 , further comprising applying a sufficient amount to the site of the injury such that the onset of clinical effect occurs in less than about 30 minutes. 
     
     
         15 . The method of  claim 1 , wherein the carrier is a gel or cream. 
     
     
         16 . The method of  claim 14 , further comprising adding at least one adjuvant selected from the group consisting of a penetration enhancer, anti-oxidant, stabilizer, and mixtures thereof to the carrier. 
     
     
         17 - 19 . (canceled) 
     
     
         20 . The method of  claim 1 , wherein the drug is administered via implantation or injection at the site of injury. 
     
     
         21 - 22 . (canceled) 
     
     
         23 . The method of  claim 1 , wherein the drug is incorporated into a delivery system selected from the group consisting of a gel, a matrix, microparticles, a pellet, an insert, a colloidal material, and mixtures of any of the foregoing. 
     
     
         24 . The method of  claim 1 , wherein the drug is administered to create a depot under the skin at the site of the injury. 
     
     
         25 . The method of  claim 1 , wherein a dopamine agonist is applied to the site of the injury, wherein the drug further comprises a skeletal muscle relaxant, an opioid agonist, an SNRI, a local anesthetic agent, an NMDA antagonist; and any combination thereof topically to the site of the injury. 
     
     
         26 - 39 . (canceled)